Sitagliptin Impurity 95 CAS 2309520-11-2
| CAS No. | 2309520-11-2 |
| Molecular Formula | C16H15F6N5O |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a certified reference material (CRM), Sitagliptin Impurity 95 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
CATO supplies Sitagliptin Impurity 95 (CAS 2309520-11-2), a pharmacopoeial impurity reference standard (molecular formula C16H15F6N5OHCl, MW 443.78 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Sitagliptin Impurity 95 (C16H15F6N5OHCl) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 8.0, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 443.78 g/mol, it falls into the moderately-high-molecular-weight range. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.
Physical & Chemical Properties
| Molecular Formula | C16H15F6N5O HCl |
| Molecular Weight | 443.78 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at room temperature, protect from light |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1999 |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 5 |
Related Sitagliptin Standards
- Sitagliptin Impurity 17 (CAS 1036273-20-7)
- Sitagliptin Impurity 966 (CAS 1151240-88-8)
- Sitagliptin Impurity 14 (CAS 1151240-91-3)
- Sitagliptin Impurity 12 HCl (CAS 1151240-91-3（free base）)
- Sitagliptin Impurity 77 (CAS 1152439-73-0)
- Sitagliptin Impurity 97 (CAS 1169707-29-2)
- Sitagliptin Tablets EP Impurity FP-E HCl (CAS 1204818-19-8)
- Sitagliptin Impurity 15 (CAS 1217809-78-3)
Recommended Standards
- Nicardipine Impurity 68 (CAS CATO-C4X-171068)
- Triamcinolone Acetonide Impurity 36 (CAS 159210-07-8)
- Brivaracetam Impurity 91 (CAS CATO-C4X-200791)
- Ethyl 3-((4-bromophenyl)amino)-3-oxopropanoate (CAS 79612-79-6)
- 1-(4-Chlorophenyl)-2,2,2-trifluoro-N-methylethan-1-amine (CAS 1154312-42-1)
- Erythromycin Impurity 13 (CAS 58781-38-7)
- 3-Fluoro-4-(methylsulfonyl)benzoic Acid (CAS 185945-88-4)
- (3-Aminoazetidin-1-yl)(p-tolyl)methanone (CAS 1340352-82-0)
- (S)-2-((1-Benzylpiperidin-3-yl)(cyclopropyl)amino)ethanol (CAS 1353996-34-5)
- Semaglutide Impurity 123 (CAS 71997-93-8)
Why CATO?
- ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
- 130,000+ catalog items in stock, COA supplied with every batch
- Worldwide shipping with full export documentation (HS code guidance available)
- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com